Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Irish Clinical Oncology Research Group |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00814541 |
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with bortezomib may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with doxorubicin and dexamethasone works in treating patients with multiple myeloma that has relapsed or not responded to treatment.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: bortezomib Drug: dexamethasone Drug: doxorubicin hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Phase II Study to Assess the Safety, Efficacy, and Tolerability of Combination Therapy With Velcade (Bortezomib), Doxorubicin, and Dexamethasone (PAD) as Therapy for Patients With Relapsed or Refractory Multiple Myeloma |
Estimated Enrollment: | 69 |
Study Start Date: | December 2005 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive bortezomib IV on days 1, 4, 8, and 11 and doxorubicin hydrochloride IV continuously on days 1-4. Patients also receive oral dexamethasone on days 1-4 (and days 8-11 and 15-18 of course 1 only). Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 2 months for 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma
Patients must meet 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Ireland | |
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital | Recruiting |
Dublin, Ireland, 24 | |
Contact: Helen Enright, MD, FRCPI, FRCPath 353-1-414-3912 helen.enright1@amnch.ie | |
Mater Misericordiae University Hospital | Recruiting |
Dublin, Ireland, 7 | |
Contact: Peter O'Gorman, MD 353-1-803-2000 | |
Mid-Western Cancer Centre at Mid-Western Regional Hospital | Recruiting |
Limerick, Ireland, 0009 | |
Contact: Maeve Leahy, MD 353-61-482-900 | |
St. James's Hospital | Recruiting |
Dublin, Ireland, 8 | |
Contact: Paul Browne, MD 353-1-410-3756 | |
St. Vincent's University Hospital | Recruiting |
Dublin, Ireland, 4 | |
Contact: Donald M. McCarthy, MD 353-1-209-4280 d.mccarthy@st-vincents.ie | |
University College Hospital | Recruiting |
Galway, Ireland | |
Contact: Mike O'Dwyer, MD 353-91-524-222 | |
United Kingdom, England | |
Leeds Cancer Centre at St. James's University Hospital | Recruiting |
Leeds, England, United Kingdom, LS9 7TF | |
Contact: Gordon Cook, MD, PhD 44-113-206-7940 | |
Saint Bartholomew's Hospital | Recruiting |
London, England, United Kingdom, EC1A 7BE | |
Contact: Jamie Cavenagh, MD 44-207-601-8202 | |
University College Hospital | Recruiting |
London, England, United Kingdom, NW1 2BU | |
Contact: Kwee Yong, MD 44-845-155-5000 | |
United Kingdom, Northern Ireland | |
Belfast City Hospital Trust Incorporating Belvoir Park Hospital | Recruiting |
Belfast, Northern Ireland, United Kingdom, BT9 7AB | |
Contact: Curly Morris 44-28-9026-3733 |
Principal Investigator: | Curly Morris | Belfast City Hospital Trust Incorporating Belvoir Park Hospital |
Study ID Numbers: | CDR0000629438, ICORG-05-01, 2005-000395-41, EU-20893 |
Study First Received: | December 24, 2008 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00814541 |
Health Authority: | Unspecified |
refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Dexamethasone Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias |
Hemostatic Disorders Doxorubicin Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics Enzyme Inhibitors |
Antibiotics, Antineoplastic Hormones Glucocorticoids Pharmacologic Actions Protease Inhibitors Neoplasms Autonomic Agents Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents Central Nervous System Agents |